Healthy
Conditions
Keywords
Phase 1, Bioequivalence, Pharmacokinetics, Food, Healthy Adult
Brief summary
To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145
Detailed description
This Phase 1, randomized, open-label study of IPI-145 will be conducted in 2 parts. Part 1 will be conducted in 2 cohorts. Cohort 1 will consist of 32 healthy subjects, and Cohort 2 will consist of 52 healthy subjects. Subjects in each cohort will receive 2 doses of IPI under fasted conditions in a 2-period, 2-sequence crossover design. Dosing in Period 1 and Period 2 will be separated by at least 7 days. Part 2 is a 2-period, 2-sequence crossover design to assess the effect of a high-fat meal on the PK of the IPI-145 in 20 subjects. Subjects will receive single oral doses under fed (high-fat meal) and fasted conditions, separated by at least 7 days.
Interventions
High single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) high single oral dose
DRUGIPI-145
Low single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) low single oral dose
Sponsors
SecuraBio
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Men or women of non-child bearing potential between 18-50 years of age * Body Mass Index (BMI): 18.0 - 32.0 kg/m2. * Healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations * Provided written informed consent prior to any study specific procedures
Exclusion criteria
* Women of childbearing potential * Healthy subjects: positive screening test for hepatitis B surface antigen, hepatitis C antibody, or HIV-1/HIV-2 antibodies * ECG at screening showing QTcF ≥ 450 msec * Evidence of clinically significant medical conditions * History of gastrointestinal disease or surgery that may affect drug absorption * Positive T-Spot (tuberculosis)TB test at screening * Any active infection at the time of screening or admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of bioequivalence of the IPI-145 test and reference formulations | 24 Hours |
| Pharmacokinetic Parameter (AUClast ) of IPI-145 | Over 24 hours |
| Pharmacokinetic Parameter (AUCinf ) of IPI-145 | Over 24 hours |
| Pharmacokinetic Parameter (Cmax) of IPI-145 | Over 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events following administration of IPI-145 | 7 weeks |
Countries
United States
Outcome results
None listed